tbuckley/cabot-search huggingface dataset:
The use of adjuvant chemotherapy in resected stage IB-IIIA non–small cell lung cancer (NSCLC) and comparison to the TriNetX database.
Authors: Ayesha Shameem, Steven Jubelirer, Frank Annie, Christine A. Welch
Journal: Journal of Clinical Oncology (2022)

29 Background: Adjuvant cisplatin-based chemotherapy (AC) is the standard of care for completely resected stage IB (tumor size &gt; 4cm), II, and IIIA non small cell lung cancer (NSCLC) patients. Several randomized clinical trials have shown varying levels of survival benefit for patients treated with AC compared to surgery alone. Methods: A retrospective study was performed regarding the use of adjuvant chemotherapy comparing Charleston Area Medical Center (CAMC) patients to those in the TriNetX database in the years 1998-2017. Inclusion criteria were patients &gt; 18 years of age, completely resected (R0), stage IB (tumor size &gt; 4 cm) through stage IIIA (R0) NSCLC. SAS 9.3 was used for data analysis. Results: The populations included two hundred and thirty-six (CAMC) and 4,364 (TriNetX) patients. The CAMC population was 98% Caucasian, 63% male with an average age of 65±10 years. The TriNetX population was 66% Caucasian, 57% male with an average age of 67±10 years. The 5-year overall survival (OS) in the CAMC database between chemotherapy and non-chemotherapy groups was not statistically significant (49.5% vs 49.8%, p = 0.8, respectively). In the TriNetX database, the 5-year OS for the chemotherapy group was significantly higher compared to the non-chemotherapy groups (61.2% vs 54.0%, p &lt; 0.05, respectively). Cox proportional hazards model was used to determine the factors influencing 5-year OS in the CAMC population. Results showed that patients &gt;65 years of age were 2.2 times (95% CI: 1.53-3.2) more likely to be dead in 5-years. With each increase in stage patients were 1.3 times (95% CI: 1.0-1.8) more likely to be dead in 5-years. Moreover, patients without coronary artery disease were 1.7 times (95% CI: 1.2-2.4) more likely to be dead in 5-years. Conclusions: Regardless of treatment, about half of CAMC patients were alive at 5 years, while a higher OS was seen in the TriNetX chemotherapy group. Regression analysis of the CAMC population showed that chemotherapy was not a significant variable in 5-year OS. Differences in survival between CAMC and TriNetX could be due to the large number of comorbidities in the CAMC population, patient refusal to chemotherapy, particularly those &gt;65 years, and incomplete planned dose due to side effects of adjuvant chemotherapy. We conclude that several barriers may impact the use of adjuvant chemotherapy in non-trial settings in the CAMC population.
Determinants of low-value imaging for patients with low-to-intermediate risk microscopic hematuria.
Authors: Sarah A Birken, Alexandra Peluso, Cheyenne Wagi, Richa Bundy, Lauren Witek, Bridget C. Krol, Ram Pathak, Matthew E. Nielsen, Richard Matulewicz, Michael L. Parchman, Ajay Dharod
Journal: Journal of Clinical Oncology (2022)

27 Background: In the US, two million people are referred to urologists for the evaluation of microscopic hematuria (MH). MH guidelines were revised in 2020 by the American Urological Association, recommending that only patients at high risk for malignancy based on age, smoking history, or urinalysis receive computed tomography (CT) imaging. We found in previous studies that providers continued to use CT for patients with low-to-intermediate risk, representing low-value care. To understand reasons for continued CT use for patients with low-to-intermediate risk MH, we assessed determinants of low-value care in a concurrent mixed-method study. Methods: We stratified patients with a urology consultation within 180 days of a urinalysis documented in one academic medical center’s electronic health record between 1/1/15 and 7/1/21 into high-, intermediate-, and low-risk categories and validated risk designation in a chart review of a 5% subsample. We defined low-value care as CT for patients with low-to-intermediate-risk MH. To assess determinants of low-value MH care, we conducted semi-structured interviews with primary, urology, and gynecology providers (n = 7) identified through our professional networks. Results: Six hundred nineteen patients were referred to urology for MH. 58.6% were high-risk, 33.6% intermediate-risk, 4.4% low-risk, and 3.4% were undefined. 15.9% of intermediate-risk (n = 33) and 11.1% of low-risk (n = 3) patients received CT. Of the 14 patients referred to urology post-guideline change, none with low-to-intermediate-risk received CT. Interviews demonstrated substantial variation in approaches to MH evaluation. Urologists were largely aware of the revised guideline but noted inappropriate evaluation before referral, unnecessary referrals, and inefficiency in evaluation following referral. Lacking accessible data for risk stratification, other providers’ approaches were varied but driven by a common goal of ruling out renal malignancy, based on medical school training and institutional norms. Conclusions: Low-value care was limited but persistent and may be driven by a lack of resources to support risk-stratified MH evaluation, including accessible risk stratification data and clear guidelines for appropriate evaluation. This is consistent with a lack of practical guidance for implementing MH evaluation guidelines. In future studies, we will develop strategies to facilitate risk-stratified MH evaluation in practice.
Racial and ethnic disparities in the cervical cancer screening cascade in three U.S. health care settings.
Authors: Jennifer C. Spencer, Jane Kim, Lei Wang, Jasmin A. Tiro, Sarah Feldman, Aruna Kamimeni, Celette Sugg Skinner, Anne Marie McCarthy, Jennifer Haas
Journal: Journal of Clinical Oncology (2022)

109 Background: There are wide disparities in cervical cancer incidence and mortality in the US by race and ethnicity. Our objective was to characterize racial and ethnic differences in routine cervical cancer screening and follow-up of abnormal findings across three US healthcare settings. Methods: We used 2016 to 2019 data from three sites participating in the METRICS research center, part of the PROSPR II consortium. We evaluated screening among average risk, screen-eligible patients receiving care at participating sites, by race and ethnicity as captured in the EHR. Among patients with a high-risk abnormal finding, we evaluated the proportion receiving colposcopy or biopsy within six months. We conducted multivariate regression to assess the extent to which clinical, socioeconomic, and structural characteristics mediate observed differences in screening. Results: We identified 188,415 eligible patients; 74.6% received cervical cancer screening during the 3-year study window. Screening use was lower among non-Hispanic Black (66.8%) patients and higher among Hispanic (82.5%), Asian/Pacific Islander (75.8%) patients, and those who identified as multi-racial or “other” race (75.8%) compared to non-Hispanic White (71.4%) patients. In multivariate regression, most differences were explained by the distribution of patients across sites, with the lowest screening rate observed at the site caring for the majority of both Black and Hispanic patients. However, Hispanic patients remained more likely to be screened even after controlling for a variety of clinical and sociodemographic factors (Risk Ratio: 1.14 [1.12, 1.16]). Among those receiving a screening test, Black and Hispanic patients were more likely to receive Pap-only testing (vs. HPV DNA co-testing) compared to non-Hispanic White patients and were more likely to have abnormal findings. Follow-up from abnormal results within six months was low for all groups (68.7%) but highest among Hispanic participants (77.7%). Conclusions: In a large cohort of patients receiving care in three community settings, cervical cancer screening and follow-up were lower than national targets. Lower screening for Black women is strongly driven by insurance and site of care, underscoring the value of addressing systemic inequity. More research is needed to characterize the relatively higher screening for Hispanic women, which is not explained by observed individual or systemic factors. Additionally, it is crucial to focus on follow-up after abnormalities are identified, which is low for all populations.
Best practices in achieving patient diversity in oncology clinical trials.
Authors: Andrea Curry, Gregory A. Vidal, Judith R Greener
Journal: Journal of Clinical Oncology (2022)

87 Background: The underrepresentation of Black patients in cancer clinical trials in the United States has been well documented. While a multitude of recommendations exist from government organizations, academic institutions, industry sponsors, and commercial groups on approaches designed to increase enrollment, there is a lack of evidence as to the effectiveness of these recommendations in real-world settings. The West Cancer Center &amp; Research Institute (WCCRI), a community oncology center in the greater Memphis, TN area, has consistently conducted trials in which Black patients are well-represented. Of all oncology clinical trials conducted at WCCRI in 2021, Black patients represented 29.9% of the total enrolled population. To further extend the literature on successful methods to achieve greater trial diversity, enrollment tactics used by WCCRI were explored to understand best practices and assess scalability to other oncology centers. Methods: A total of 35 qualitative in-depth interviews were conducted with multiple constituencies associated with WCCRI to obtain a holistic view of clinical trial practices. Interviews were held between March and April 2022. Included were Black patients who participated in a clinical trial, Black patients that declined participation in a clinical trial, caregivers of these patients, WCCRI staff, and community leaders in the Memphis, TN area. All patients interviewed had a history of solid malignancies and were treated at WCCRI between January 2018 and December 2021. The study was considered minimal risk research and all participants provided informed consent before study participation. Results: This research underscored the fact that barriers to enroll Black patients are complex and involve challenges at various structural levels including the system, individual, and interpersonal levels. WCCRI practices were found to incorporate tactics at each of these levels, leading to the ability of this community oncology center to enroll representative proportions of Black patients into its oncology trials. Examples of tactics that reach into the community include coordinating with local leaders to provide residents with health education; outreach by Black WCCRI staff, diverse PIs, and ambassadors to dispel myths about a cancer diagnosis and treatment; and faith-based leaders guiding patients to helpful resources and supportive services provided by WCCRI. Conclusions: Results of this research build upon previous literature that suggest although some success has been identified through interventions at any one level, the greatest opportunity for achieving diversity in oncology trials comes from multilevel interventions. Emphasis should be placed on crafting tactics that simultaneously address factors in each of these levels to consistently achieve enrollment diversity.
Real-world uptake and concordance of actionable genetic mutations between tissue NGS and liquid biopsy in oncology patients in a safety-net hospital: A single center analysis.
Authors: Steven Badami, Kimberly Boldig, Abhinav Rohatgi
Journal: Journal of Clinical Oncology (2022)

426 Background: Advances in genomic mutation profiling have helped strengthen the management of cancer, however access to these advances can be challenging in hospitals serving majorly low-income neighborhoods due to socioeconomic factors. In a retrospective cohort study at our safety net hospital, serving lower socioeconomic populations, we identified the real-world uptake of tissue based next-generation sequencing (NGS) and liquid biopsy (ctDNA) in treated oncology patients. Methods: Records from 85 solid tumor patients treated at UF Health were evaluated for specific demographics and for completion of liquid biopsies and also NGS of patients’ tumors. 25 of those patients had completed liquid biopsies and were included. Genomic mutation profiles were stratified by liquid biopsies and whether or not NGS was completed. Concordance of multiple variant mutations between NGS and liquid biopsy were analyzed to determine if both tests were actionable. Results: Of these 85 patients, 25 obtained genomic mutation profiles from liquid biopsies with 10 also obtaining profiles from NGS. Of the profiled tumors, 64% contained actionable variant mutations for a specific therapy. Comparative analysis between patients with liquid biopsies and NGS revealed a concordance rate of 70% in variant mutation identification and 20% concordance rate in actionable variant mutations. Additionally, of the patients who received only liquid biopsies, 52% contained variant mutations that were actionable. Conclusions: Our data shows that 64% of patients with liquid biopsy and 70% with NGS had actionable mutations. The low concordance in actionable mutations between NGS and liquid biopsy suggests that both tests should be done to inform cancer management. Our data demonstrates that hospitals that serve low-income populations have limited access in obtaining genomic mutation profiling through liquid biopsies or NGS due to the socioeconomic challenges our patients face. Cancer centers in safety-net hospitals should address challenges to obtaining actionable data provided by genetic mutation profiling to inform treatment options for those patients.[Table: see text]
Family history screening following new diagnoses of leukemia versus solid malignancies.
Authors: Benjamin Aaron Bleiberg, Jackson Steinkamp, Ximena Jordan Bruno
Journal: Journal of Clinical Oncology (2022)

333 Background: Family history screening for malignancies informs the need for genetic testing of cancer patients and their families. Associations between heritable mutations and solid malignancies are well-established, but germline contributions to hematologic malignancies may be of similar importance. For instance, the pooled risk of a group of heritable transcription factor mutations including RUNX1, GATA2, and CEBPA may play a role in up to 15% of new cases of leukemia. Standard of care for new patient visits in malignant hematology clinics should involve thorough family screening like that of solid malignancies more classically associated with heredity. Methods: All patients presenting to an academic hospital system's outpatient GI, breast, and leukemia clinics for new patient visits in a 3-month period were identified accounting for 706 participants (breast n=258 (36.5%), GI n=303 (42.9%), leukemia n=145 (20.5%)). Retrospective chart review was completed by EMR report, which aggregated data from individuals identified by their cancer diagnosis. Groups were compared along the following variables: percentage with completed 1 st degree (parents and siblings) family history of malignancy screening, percentage with completed 2 nd degree (grandparents, aunts, and uncles) family history screening. Chi-squared significance testing was completed to identify significant (p&lt;0.05) differences in screening, which was considered completed if entered in the searchable summary information of the patient’s chart. Results: Patients presenting for new patient visits in breast (77.1%) cancer clinic had significantly higher rates of 1 st degree family history of malignancy screening than those presenting with new diagnoses of leukemia (62.1%). The comparison of 1 st degree screening for GI (71.6%) cancer patients and leukemia patients was not significant. Rates of 2 nd degree family history screening were significantly higher for patients with new diagnoses of breast (61.6%) and GI (37.0%) cancers as compared to those with leukemia (24.8%). The combined cohort of GI and breast cancer patients had significantly greater rates of 1 st (74.2%) and 2 nd degree (48.4%) family history screening than patients with new diagnosis of leukemia. Conclusions: There is growing appreciation of heritable germline contributors to leukemia pathogenesis. However, there remains a deficit in clearly documented, easily referenced family history screening for malignancies in patients with new diagnoses of leukemia when compared to patients with new diagnoses of classically heritable solid malignancies.[Table: see text]
Between and within drug variation in copayments for common oral anti-cancer medications at an academic medical center.
Authors: Scott Swartz, Mackenzie Clark, Jared White, Mimi Lo, Arjun Gupta, Tracy Kuo Lin, Fumiko Chino, Meera Vimala Ragavan
Journal: Journal of Clinical Oncology (2022)

18 Background: The use of oral anti-cancer medications- which are often high priced with significant cost sharing to the patient- is increasing. Transparency of out-of-pocket costs and payment responsibility has historically been limited due to the wide variation in coverage by insurance plans and pharmacy benefits. Our study utilized a novel pharmacy database to describe within-drug and between-drug variation in patient copayments for ten common oral anti-cancer medications. Methods: We conducted a retrospective cohort study including all patients prescribed an oral cancer-directed therapy through the University of California, San Francisco (UCSF) Specialty Pharmacy between January 1,2021 and December 31, 2021. The unit of analysis was defined as patient-drug. Copayments were standardized as 30-day costs. Data was abstracted through our institution’s Specialty Pharmacy prescribing database and linked to demographic data through the institutional electronic medical record system. Between drug variation in copayments was analyzed using Pearson chi square tests. Results: There were 1,357 total patient-drug combinations over the study period. Medicare Part D was the primary payor (44%) followed by commercial insurance (25%). The ten most frequently prescribed medications (Table) accounted for 50% of all oral anti-cancer prescriptions. Minimum monthly copayment for all medications was $0. There were significant differences across medications in the percentage of patients with a mean copayment above $150 (Χ2 = 33.9, p &lt; 0.001) and percentage of patients receiving financial assistance (Χ2 = 63, p &lt; 0.001). Conclusions: There was a high amount of within-drug and between-drug variation in copayments within an integrated specialty pharmacy program. It is essential to identify patients with high copayments early on in cancer treatment and connect them with tangible resources to help mitigate the growing financial impact of these medications.[Table: see text]
Evaluating the effect of a scalable cancer-navigation program on total cost of care.
Authors: Scott Campbell Worland, Margot Albin, Brian Dorsey, Kevin Fosnocht, Juan Gomez, Denise Johnstone, Alphan Kirayoglu, Edward Licitra, Ravi Bharat Parikh, Kush Sachdeva, Keith Thompson, Scott Voigt, Shannon Woerner, Robert Jeffrey Green
Journal: Journal of Clinical Oncology (2022)

4 Background: Cancer-patient navigation programs have been shown to reduce total cost of care while improving outcomes. Previous research has focused on navigation programs embedded within a single institution or a single network of practices. We explore whether an independent cancer-patient navigation program deployed in collaboration with a Medicare Advantage (MA) plan can demonstrate similar cost savings when deployed across a wide variety of practice settings in the state of New Jersey. Methods: We conducted a retrospective observational study to determine the per member per month (PMPM) total cost of care (TCOC) difference between cancer patients with and without a navigation intervention provided by Thyme Care, a technology-enabled virtual cancer-navigation platform. The team, staffed by both lay-health workers and nurses, was assigned members of a single MA plan’s population in NJ beginning on March 2, 2021. Patients with a cancer-specific ICD-10 code who received systemic antineoplastic therapy were eligible for the program. The navigation team coordinated care, addressed barriers to care, facilitated goals of care discussions, and conducted proactive and reactive symptom assessment. The cadence of the symptom assessment was determined by both patient and disease-specific criteria. Concerning responses were triaged to the patient’s oncology team the same day. The study period was from January 1, 2018 to June 13, 2022. The primary outcome was TCOC excluding part D drug spend. We compared TCOC for patients who received the intervention to a control group of eligible individuals that were matched using propensity scores derived from clinical and demographic covariates. We used a repeated measure generalized linear model to estimate the monthly effect of navigation on TCOC. Additionally, we conducted a monte-carlo sensitivity analysis to provide an upper and lower bound on the cost savings. Results: Of 4,172 eligible members, 662 were in the treatment group (across 25 community practices and 45 hospital based practices) and 3,510 were in the control group (across 58 community practices and 73 hospitals). The propensity matching resulted in 188 members in both the treatment and the control group (376 total). The mean TCOC declined $459 more PMPM for the navigated group compared to the non-navigated group. The sensitivity analysis suggested a plausible range of $209-708 PMPM savings in the intervention group. Conclusions: This is the first study to demonstrate that a cancer-navigation program can reduce overall costs when deployed in collaboration with a health plan across a wide geography and range of practice types.